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Table 1 Distribution of the Expected Benefit and Improvement of Expected Benefit level according to the type of application

From: Medical device assessment: scientific evidence examined by the French national agency for health – a descriptive study

 

Total N (%)

New N (%)

Modification N (%)

Renewal N (%)

Sufficient EB*

79 (77.5)

46 (68.7)

13 (92.9)

20 (95.2)

IEB level I

1 (1.0)

0 (0.0)

1 (7.1)

0 (0.0)

IEB level II

8 (7.8)

2 (3.0)

0 (0.0)

6 (28.6)

IEB level III

5 (4.9)

3 (4.5)

1 (7.1)

1 (4.8)

IEB level IV

15 (14.7)

11 (16.4)

1 (7.1)

3 (14.3)

IEB level V

50 (49.0)

30 (44.8)

10 (71.4)

10 (47.6)

Insufficient EB

23 (22.5)

21 (31.3)

1 (7.1)

1 (4.8)

Total

102

67

14

21

  1. * EB: expected benefit.
  2. IEB: improvement of expected benefit.